NCT02382263

Nab-paclitaxel in Combination With Gemcitabine in Fragile Patients With Advanced Pancreatic Cancer

Phase I/II Study to Assess the Efficacy and Safety of Nab-paclitaxel in Combination With Gemcitabine for the Treatment of Fragile Patients With Advanced or Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: PH Research, S.L. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In the list of cancer mortality by type of cancer pancreatic cancer ranks 4th in USA and the 6th in Europe. The estimated figures for 2010 in the USA were 42,000 new cases and 36,000 deaths from pancreatic cancer. The survival rate at 5 years after diagnosis is 4.6% in the USA. In Europe the figures are similar, with survival at 1, 3 and 5 years of 16%, 6% and 4%, respectively. Most patients are diagnosed in advanced stages that are no longer operable, so that treatment goals are often the prolongation of survival and palliation of symptoms. The aim of the study is to explore whether the new combination nab-paclitaxel plus gemcitabine is a therapeutic advance for this fragile population for which it is assumed that some modifications in dose and schedule of administration may be necessary in patients with good performance status. It is ultimately to find out the clinical benefit of this combination, but first making sure that dose and schedule of the combination are tolerable for these fragile patients. For this, the investigators have chosen a design that includes two stages: the first step aimed at choosing the safest treatment regimen for these patients among a group of treatment regimens used in other clinical trials. The second step will evaluate the effectiveness of the two regimens with the better results in the previous step.

Conditions

• Advanced Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4	Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 days 1 \& 15 in a 28 days cycle
DRUG	Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4	Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle
DRUG	Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4	Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1 \& 15 in a 28 days cycle
DRUG	Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4	Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1,8 \& 15 in a 28 days cycle

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-03-06
• Last updated: 2016-07-06

Locations

15 sites across 1 country: Spain